ALX Oncology(ALXO) - 2025 Q1 - Quarterly Report

Financial Performance - Net loss for the three months ended March 31, 2025, was $30,754,000, compared to a net loss of $35,581,000 for the same period in 2024, representing a reduction of about 13.5%[18]. - The company reported a total comprehensive loss of $30,911,000 for the three months ended March 31, 2025, compared to $35,809,000 for the same period in 2024, a reduction of approximately 13.5%[21]. - The net loss for the three months ended March 31, 2025, was $30.8 million, compared to a net loss of $35.6 million for the same period in 2024, reflecting a 13.5% improvement[44]. - For the three months ended March 31, 2025, the net loss was $30.8 million, a decrease of 14% compared to a net loss of $35.6 million for the same period in 2024[113]. - The accumulated deficit reached $651.9 million as of March 31, 2025, with expectations of continued net losses in the foreseeable future[139]. Assets and Liabilities - Total current assets decreased from $134,352,000 as of December 31, 2024, to $102,532,000 as of March 31, 2025, a decline of approximately 23.7%[16]. - Total liabilities decreased from $34,157,000 as of December 31, 2024, to $32,605,000 as of March 31, 2025, a decrease of approximately 4.5%[16]. - Total stockholders' equity decreased from $113,618,000 as of December 31, 2024, to $88,295,000 as of March 31, 2025, a decline of approximately 22.3%[16]. - As of March 31, 2025, the company's cash, cash equivalents, and investments totaled $107.0 million, down from $131.3 million as of December 31, 2024[42]. - The fair value of cash equivalents and available-for-sale investments decreased to $105.3 million as of March 31, 2025, from $129.2 million as of December 31, 2024[48]. Research and Development - Research and development expenses decreased from $31,717,000 in Q1 2024 to $23,888,000 in Q1 2025, a decrease of approximately 24.7%[18]. - Total research and development expenses for the three months ended March 31, 2025, were $23.9 million, a decrease of 24.8% compared to $31.7 million for the same period in 2024[44]. - Clinical and development costs decreased by $7.0 million to $10.5 million, primarily due to the completion of manufacturing clinical trial materials for evorpacept[133]. - The company expects to incur significant expenses and increasing operating losses in the foreseeable future due to ongoing research and development activities[114]. - The company is developing ALX2004, a novel EGFR-targeted antibody-drug conjugate (ADC), which is designed to overcome limitations of earlier-generation EGFR-targeted ADCs[97]. Stock and Financing - The weighted-average shares of common stock used to compute net loss per share increased from 50,120,758 in Q1 2024 to 53,359,338 in Q1 2025, an increase of about 6.0%[18]. - The Company raised approximately $30 million through the sale of 2,404,855 shares under its at-the-market equity offering program as of March 31, 2025[65]. - The company completed a follow-on public offering in October 2023, raising approximately $58.9 million in net proceeds[147]. - The company expects to finance operations through equity offerings, debt financings, and collaborations, with a focus on raising additional capital[140]. - The company has a secured term loan facility of up to $100 million, with an initial draw of $10 million and future maturities totaling $10,600,000 as of March 31, 2025[60][62]. Clinical Trials and Product Development - The lead product candidate, evorpacept, demonstrated an overall response rate (ORR) of 41.3% in the intent-to-treat population in the ASPEN-06 Phase 2 clinical trial, compared to 30% for the historical control[94]. - In the same trial, evorpacept showed a median duration of response (mDOR) of 15.7 months and a median progression-free survival (mPFS) of 7.5 months, outperforming the control group[94]. - Evorpacept demonstrated a confirmed overall response rate (ORR) of 52% in the Evo-TRP treatment arm compared to 22% for the TRP control arm in the interim Phase 2 clinical data from the ASPEN-06 trial[99]. - The ASPEN-07 trial reported an unconfirmed ORR of 59% for evorpacept plus enfortumab vedotin in patients with locally advanced or metastatic urothelial cancer[106]. - The company filed an IND application for ALX2004 in March 2025, which was cleared by the FDA in April 2025 for a Phase 1 clinical trial[112]. Operational Challenges - The company has not generated any revenue from product sales, licenses, or collaborations to date, and is heavily reliant on the success of its lead product candidate, evorpacept[176]. - The company has encountered setbacks in clinical trials, including the failure to meet primary endpoints in recent trials, which may impact future development[196]. - The company anticipates ongoing challenges in clinical trial enrollment due to factors such as COVID-19 and competition for eligible subjects[202]. - The company must navigate various regulatory requirements and potential delays in clinical trials, which could hinder the commercialization of its product candidates[194]. - The company has faced delays in clinical trial enrollment and retention, which could impact regulatory submissions and marketing approvals[201]. Compliance and Regulatory Issues - The company received a compliance notice from Nasdaq on April 23, 2025, regarding its common stock closing below the minimum bid price requirement of $1.00 per share for 30 consecutive business days, with a compliance period until October 20, 2025[88]. - The company has not identified any material changes to its critical accounting policies and estimates from the previous year[160]. - The company has no off-balance sheet arrangements as defined by SEC rules[158]. - The company is exposed to interest rate risk, with borrowings of $10.0 million under a Loan Agreement, which bears interest at a floating rate[164]. - The company has not experienced any realized losses on its deposits of cash, cash equivalents, or investments during the periods presented[166].